Estrogen and Fear in PTSD

PHASE3CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 24, 2020

Primary Completion Date

May 29, 2024

Study Completion Date

December 2, 2024

Conditions
PTSD
Interventions
DRUG

Estradiol

2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)

DRUG

Placebo oral tablet

2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)

BEHAVIORAL

Prolonged Exposure (PE) therapy

There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.

Trial Locations (2)

19104

University of Pennsylvania Perelman School of Medicine, Philadelphia

77054

The University of Texas Health Science Center at Houston (UTHealth Houston), Houston

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER

NCT04192266 - Estrogen and Fear in PTSD | Biotech Hunter | Biotech Hunter